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Change proposals 2020: LC/UV-DAD, LC-PAD and expression of related substances limits

Change proposals 2020: LC/UV-DAD, LC-PAD and expression of related substances limits

In July 2020, the BP reached out to Users to consult on change proposals. Since the consultations closed in September 2020, we have worked to review all the comments and made recommendations to the relevant Expert Working Groups and the British Pharmacopoeia Commission:

LC/UV-DAD for Identification

Here we proposed introducing LC/UV-DAD (Diode Array Detection), also known as photo-diode array (PDA) detection, as a routine identification test option in BP monographs. You told us that this test was widely adopted, offered efficiency improvements and alignment with registered methods and other pharmacopoeias. This test was introduced in some monographs from the BP 2022 onwards.

LC-PAD in Related substances and Assay

Here we proposed introducing LC-PAD (Pulsed Amperometric Detection) in Related substances and Assay tests where UV detection is not suitable. You told us that LC-PAD methods can mean that complex derivatisation methods and semi-quantitative TLC methods are avoided. These tests will be introduced in limited circumstances and no earlier than the BP 2024.

Expression of related substances limits

Here we propose to begin the process of moving to fully numerical limits in LC and GC-related substances tests in BP monographs. You told us that this change would make it easier to understand and use BP tests due to greater alignment with registered methods and other pharmacopoeias. You will begin to see this change introduced gradually from the BP 2023.